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Hawai'i CFS

Appeals Court Ruling Allows Novel Genetically Engineered Soy Leghemoglobin in Impossible Burgers

May 03, 2021
Center for Food Safety

SAN FRANCISCO—Today, the U.S. Court of Appeals for the Ninth Circuit issued a decision in Center for Food Safety's (CFS) lawsuit challenging the Food and Drug Administration's (FDA) approval of soy leghemoglobin (a.k.a. "heme"), the novel genetically engineered (GE) color additive that makes Impossible Foods' eponymous plant-based burger, the Impossible Burger, appear to "bleed" like real meat. In an unpublished opinion, the court ruled that concerned consumers have the right to challenge FDA's determination, but affirmed the FDA's approval of the novel color additive, even though preliminary animal lab data submitted by Impossible Foods indicated potential health risks including blood clot issues, anemia, and kidney damage.  

In response to the appeals court's decision, Center for Food Safety's senior attorney Sylvia Wu issued the following statement: 

"We are disappointed by the court's ruling today, which will allow Impossible Burger and other meatless burgers to be made with a novel genetically engineered chemical without conducting any long-term health studies. FDA is supposed to protect consumers from unsafe novel chemicals in our food supply, instead now consumers bear the burden of avoiding these GMO plant-based burgers."   


CFS originally filed the lawsuit in March 2020; oral arguments in the case were presented last month. CFS argued that FDA used a lower safety standard when it approved GE heme to be used in raw Impossible Burgers sold in grocery stores. Instead of using the color additive safety standard that specifies "convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive," FDA conflated that standard with the food additive safety standard, which does not specify that there must be "convincing evidence."  

CFS also argued that FDA approved GE heme without the animal lab study on longer-term health effects called for by FDA's own testing guidelines. Today's ruling cements FDA's food additive approval, allowing Impossible Foods and other plant-based meat companies to use GE heme for no other purposes other than make their burgers more marketable. Despite avidly supporting plant-based diets, CFS urges consumers to avoid eating these GMO plant-based burgers.   

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